Quality Management Software for Laboratories

BizzMine works on all devices, anytime, everywhere.And is available in the Cloud or On-Premises.

ISO/IEC 17025 is the main ISO standard used by testing, calibration and forensic laboratories. In most major countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test, forensic or calibration results from a lab that is not accredited.

ISO 15189 is a standard that specifies the quality management system requirements particular to medical laboratories. The standard is based on the details of ISO/IEC 17025:1999, with addition of advice to medical laboratory users. This includes requirements towards the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff.

While the ISO 15189 standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care. The first version of the ISO 15189 was published in 2003, and it was revised in 2007 to align more closely to ISO/IEC 17025. A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management.

Our team has more than 20 years of experience implementing quality management software for the laboratory industry. We help you through the smooth and painless setup of the core processes of your ISO and GxP compliant QMS in our software.